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目的 研制乙型肝炎表面抗原 (HBsAg)胶体金试剂。方法 用未加氢氧化铝佐剂的乙型肝炎血源疫苗原材料免疫BALB/c小鼠制备抗 -HBs单克隆抗体 ;应用胶体金标记抗 -HBs单克隆抗体 ;测定HBsAg胶体金试剂的稳定性 ;对该试剂进行临床考核及检定等。结果 经中国药品生物制品检定所检定 ,其灵敏度达到 1ng/ml,特异度为 10 0 % (2 0 / 2 0 ) ,精密度为 10 0 % (10 / 10 ) ,符合国家对HBsAg试剂盒的要求 ,临床考核合格 ,已通过国家药品监督管理局的新药评审 ,获国家新药证书。结论 HBsAg胶体金试剂可用于献血员HBsAg筛查、健康人群体检、乙型肝炎病毒 (HBV)感染的流行病学调查和临床诊断。
Objective To develop a Hepatitis B surface antigen (HBsAg) colloidal gold reagent. Methods BALB / c mice were immunized with raw materials of hepatitis B virus vaccine without aluminum hydroxide adjuvant to prepare anti-HBs monoclonal antibody. Colloidal gold labeled anti-HBs monoclonal antibody was used to determine the stability of HBsAg colloidal gold reagent ; The reagents for clinical assessment and verification. The results of the Chinese drug and biological products test, the sensitivity of 1ng / ml, the specificity of 100% (20/20), the precision of 10 0% (10/10), in line with national HBsAg kit Requirements, clinical examination pass, has passed the State Drug Administration review of new drugs, the new national drug certificate. Conclusion HBsAg colloidal gold reagent can be used for blood donors HBsAg screening, physical examination of healthy people, hepatitis B virus (HBV) epidemiological investigation and clinical diagnosis.